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What to know about recent eye drop recalls

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Two brands of eye drops were pulled from shelves in January and February after they were linked to a drug-resistant bacterial strain that caused at least four deaths and serious health problems in many more. Weeks later, two more types of eye drops were recalled because they posed a different type of contamination risk.

This barrage of recalls might keep you guessing about your trusted source of dry eye relief, but there are significant differences between recalls and many steps you can take to stay safe.

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I would encourage all the people out there who take eye drops to continue using them, obviously making sure they’re not using any of these that are being recalled, said Dr. Christopher Starr, clinical spokesperson for the American Academy of Ophthalmology.

Here’s what to know about these recalls.

In January, the Centers for Disease Control and Prevention and the Food and Drug Administration warned people to stop using EzriCare Artificial Tears and Delsam Pharmas Artificial Tears after the eye drops were linked to a drug-resistant strain of the Pseudomonas aeruginosa bacteria. Infections with this bacterial strain have caused the deaths of at least four people, loss of vision in 14 others, and the surgical removal of the eyeballs in four people.

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Global Pharma, which makes EzriCare eye drops and Delsam Pharmas, recalled both products in February.

In March, a Florida woman sued Global Pharma, claiming an infection caused by the eye drops was so serious that doctors had to surgically remove one of her eyes.

The FDA also warned people to stop using an eye ointment made by Global Pharma due to possible contamination.

The manufacturer of EzriCare Artificial Tears said it was recalling the product out of caution.Credit…EzriCare

The other two eye drop recalls were unrelated to the bacteria outbreak.

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On March 1, Apotex recalled prescription eye drops used to reduce eye pressure in people with glaucoma or ocular hypertension. The company recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15% because at least four bottle caps developed cracks, which could compromise the sterility of the products.

Apotex has recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15%.Credit…through the FDA

On March 3, Pharmadica recalled two batches of purely soothing 15% MSM drops because they were not sterile. These drops are used to treat eye irritation and swelling.

Pharmadica recalled two batches of purely soothing MSM 15% drops because they were not sterile.Credit…through the FDA

The CDC said that, as of May 15, the drug-resistant bacterial strain linked to the recalled EzriCare and Delsam eye drops had been found in 81 people in 18 states.

The best way to find out if you have any eye drops included in the recall is to review the recall notice provided by each company. Each alert contains details on which lot of each product was affected.

The notice for EzriCare and Delsam eye drops is here, and the notice for Global Pharma eye ointment is here. The Apotex Brimonidine Tartrate alert is here and the Pharmadica Purely Soothing alert is here.

People who have used these artificial tears and who have symptoms of an eye infection should see a doctor right away, the CDC said. Symptoms may include yellow, green, or clear discharge from the eye, redness of the eye or eyelid, increased sensitivity to light, and eye pain or discomfort.

Apotex said people who received its recalled eye drops, which were distributed between April 5, 2022 and February 22, should contact their doctor and pharmacy. The company has also provided a phone number and website where people can request a recall/return package.

An Apotex vice president, Jordan Berman, said in an email that the company had only seen four bottles with broken caps. He said one of the bottles came from a customer or consumer complaint and the other three were found in stored samples of products that the FDA requires a company to withhold in case problems like these arise.

There have been no drug safety reports of adverse health outcomes from this product, Berman said.

Pharmadica said that, as of March 3, it had not received any reports of illness or other adverse events resulting from use of the eye drops. The company did not specify how many bottles were impacted or how the bottles became unsterile.

Anyone who has problems with any of the recalled eye drops can file a report with the FDA online, by mail, or by fax.

Dr. Barbara Tylka, an optometrist at the Mayo Clinic in Rochester, Minnesota, said that, in general, eye drops are safe to use and that many people need them to treat conditions like dryness or irritation. About 117 million Americans used eye drops and eye drops in 2020, according to Statista, a market research firm.

To use eye drops safely, Dr. Tylka said people should use their own bottle and make sure it’s not expired. People who have been prescribed eye drops for a procedure like cataract surgery should stop using those products once the healing process has finished, he said.

To safely apply eye drops, she said, people should use their nondominant hand to gently tug at the lower eyelid, look up slightly, and then, with their dominant hand, put that small drop into that lower dead end in the eyelid. area.

Dr. Starr, associate professor of ophthalmology at Weill Cornell Medicine, said one thing some patients get wrong is pressing the tip of the bottle into the inner corner of the eye, which can contaminate the drops and scratch the eye’s surface. He said that when he accidentally hits the eyelid or lashes with the tip of the bottle, he considers the bottle contaminated and resterilizes or replaces it.

Dr Starr and Dr Tylka both pointed out that while the recalls were concerning, the eye drops are generally safe.

I continued to use the eyedrops every day throughout this whole thing, Dr. Starr said.

#eye #drop #recalls

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